Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
UNATI
A Non-inferiority Randomized Trial Testing an Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
2 other identifiers
interventional
10,000
1 country
1
Brief Summary
The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years). The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes. Participants will receive during 4 years an advice to drink alcohol following a Mediterranean Alcohol Drinking Pattern (MADP): consuming alcohol in moderation, avoidance of binge drinking and preference for red wine. Researchers will compare those who will receive a MADP advice with those who will receive an advice on abstention to see if the advice on MADP is not inferior than the abstention advice to prevent all-cause mortality and other chronic diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 29, 2024
CompletedStudy Start
First participant enrolled
May 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
December 12, 2024
March 1, 2024
4.1 years
March 13, 2024
December 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases
Global index of all-cause mortality, cardiovascular events, any invasive cancer, liver cirrhosis, type 2 diabetes, depression, dementia, injury requiring hospital admission, tuberculosis or other infections requiring hospitalization evaluated from the information on clinical records.
From enrollment to the end of the intervention up to 4 years.
Secondary Outcomes (1)
Comparison between groups of the incidence of the most severe outcomes
From enrollment to the end of the intervention up to 4 years
Other Outcomes (1)
Comparison between groups of invasive cancer incidence with extended follow-up
From the enrollment up to 10 or more years of follow-up
Study Arms (2)
Moderation
EXPERIMENTALAdvice about alcohol intake following a Mediterranean Alcohol Drinking Pattern: Moderation (7 or less drinks/wk in women and 14 or less drinks/wk in men), avoidance of binge drinking, consumption of alcohol with meals and preference for red wine.
Abstention
ACTIVE COMPARATORAdvice on alcohol abstention.
Interventions
Remotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months. Goals of intervention: 1. moderate consumption (7 or less drinks/wk for women, 14 or less drinks/wk for men) of red wine (a drink=150 ml). 2. always during meals 3. spread out throughout the whole week, and 4. avoidance of binge-drinking episodes. No participant will be invited to start or increase his/her alcohol intake.
Remotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months. Goals of intervention: Abstention. Message of 0 alcohol.
Eligibility Criteria
You may qualify if:
- Males aged 50-70 years, Women aged 55-75 years
- Drinkers of any alcoholic beverage initially consuming 3 or more but 40 or less drinks/wk
- Projected life expectancy more than 5 years (according to the judgment of their attending physician)
- Willing to receive advice during up to 4 years on how to improve their alcohol intake making it healthier
You may not qualify if:
- Participants without smartphone or a computer (or tablet) with Internet connection.
- Drinkers of less than 30 g of pure alcohol/wk or more than 400 g of pure alcohol/wk
- Illiteracy, inability/unwillingness to give written consent or communicate with study staff, or inadequate abilities for the use of on-line technologies
- Participants with any sever psychiatric condition or with a diagnosis of cognitive impairment or dementia.
- Participants with liver cirrhosis or prior liver cancer.
- Patients with a recent diagnosis of breast cancer (diagnosed in the last 10 years).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Navarra
Pamplona, Navarre, 31008, Spain
Related Publications (3)
Martinez-Gonzalez MA. Should we remove wine from the Mediterranean diet?: a narrative review. Am J Clin Nutr. 2024 Feb;119(2):262-270. doi: 10.1016/j.ajcnut.2023.12.020. Epub 2023 Dec 28.
PMID: 38157987BACKGROUNDMartinez-Gonzalez MA, Hernandez Hernandez A. Effect of the Mediterranean diet in cardiovascular prevention. Rev Esp Cardiol (Engl Ed). 2024 Jul;77(7):574-582. doi: 10.1016/j.rec.2024.01.006. Epub 2024 Feb 7. English, Spanish.
PMID: 38336153BACKGROUNDBarberia-Latasa M, Bes-Rastrollo M, Perez-Araluce R, Martinez-Gonzalez MA, Gea A. Mediterranean Alcohol-Drinking Patterns and All-Cause Mortality in Women More Than 55 Years Old and Men More Than 50 Years Old in the "Seguimiento Universidad de Navarra" (SUN) Cohort. Nutrients. 2022 Dec 14;14(24):5310. doi: 10.3390/nu14245310.
PMID: 36558468BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel A Martinez-Gonzalez, MD, MPH, PhD
University of Navarra
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2024
First Posted
March 29, 2024
Study Start
May 15, 2024
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
December 12, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 5 years following the main article publication. Request out of these time frame can also be submitted.
- Access Criteria
- Researchers who provide a methodologically sound proposal approved by the UNATI Steering Committee.
The generated dataset (completely anonymized) will be made available to every proficient researcher who may present a relevant research proposal to the Steering Committee for further exploitation of the data upon all the usual legal precautions for the protection of individual data will be respected.